Completed
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
What is being tested
Interferon-alfa
+ SU011248
Drug
Who is being recruted
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Over 18 Years
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: August 2004
Summary
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Official TitleA Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
750 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesAdenocarcinomaCarcinomaCarcinoma, Renal CellFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases
Criteria
3 inclusion criteria required to participate
Histologically confirmed renal cell carcinoma of clear cell histology with metastases
Evidence of measurable disease by radiographic technique
Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
3 exclusion criteria prevent from participating
Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
History of or known brain metastases
Serious acute or chronic illness or recent history of significant cardiac abnormality
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 123 locations
Suspended
Suspended
Pfizer Investigational Site
La Jolla, United StatesSuspended
Pfizer Investigational Site
La Jolla, United StatesSuspended
Pfizer Investigational Site
Los Angeles, United StatesCompleted123 Study Centers